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NCT00452426 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
A Phase 3 study, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
NCT00452426 is a Phase 3 study that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 1,000 participants.
The verdict
NCT00452426, a Phase 3 study, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
Study Summary
Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices.
Interventions
- DEVICE Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)
- OTHER benzodiazepines and opioid sedation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2007-03 |
| Est. Completion | 2007-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00452426
The ClinicalTrials.gov registry entry for NCT00452426 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ethicon Endo-Surgery, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) is the first listed.
NCT00452426 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00452426 about?
NCT00452426 is a clinical study titled "Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy". Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to sa...
What is the current status of trial NCT00452426?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2007-03. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00452426?
The interventions under investigation include: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) (DEVICE), benzodiazepines and opioid sedation (OTHER).
Who is sponsoring clinical trial NCT00452426?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
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